Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block
Primary Purpose
Upper Extremity Injury Trauma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Echogenic needle - Pajunk sonoplex echogenic needle
Non Echogenic needle - Stimuplex Braun Nonechogenic needle
Sponsored by
About this trial
This is an interventional health services research trial for Upper Extremity Injury Trauma
Eligibility Criteria
Inclusion Criteria:
- 18-60 years, both male and female scheduled for upper extremity surgery
Exclusion Criteria:
- Clinically significant coagulopathy
- Local anesthetic allergy
- Preexisting motor or sensory deficit in the operative limb
- Uncontrolled hypertension and unstable Ischemic Heart disease
- Body mass index > 35
- Patients who needs general anaesthesia for surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group Echogenic
Group Nonechogenic
Arm Description
Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle
Non echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle
Outcomes
Primary Outcome Measures
Needle tip and shaft visibility
Percentage Needle Tip & shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time*100
Secondary Outcome Measures
Duration of block procedure
Time to onset of sensory blockade
Time to onset of motor blockade
Duration of sensory blockade
Duration of motor blockade
Block success rate of echogenic and Nonechogenic group.
Full Information
NCT ID
NCT02862041
First Posted
June 28, 2016
Last Updated
August 9, 2016
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02862041
Brief Title
Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block
Official Title
Role of Echogenic Versus Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block Success Rate: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this prospective, randomized, double blinded study, the needle tip and needle shaft visibility of echogenic and nonechogenic needle were compared in ultrasound guided infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery were included in the study. Patients were randomised into two groups, group E (Echogenic) and group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted.
Detailed Description
The aim of the investigators study was to find out the better among the echogenic and nonechogenic needle in needle tip/shaft visibility and the block success rate in ultrasound guided infraclavicular brachial plexus block. Sixty patients were randomized into two groups, Group E (echogenic group) and Group NE (nonechogenic group) with thirty patients in each group. The ultrasound imaging of each nerve block was video recorded for later analysis. Recording commenced from skin puncture and stopped at the time of final needle removal (total block time). After each block the performer was asked to subjectively score the percentage time he had visualized the needle tip and needle shaft on a 5 point scale (1 = 0%-20%, 2 = 20%-40%, 3 = 40%- 60%, 4 = 60%-80%, 5 = 80%-100%). The recorded video was later analysed by an investigator. An objective measurement of percentage needle tip visibility and needle shaft visibility was calculated for each nerve block using the formula,
Time in view (needle tip) / total block time x 100
Time in view (needle shaft) / total block time x 100
The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted. Other block parameters were also compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Injury Trauma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Echogenic
Arm Type
Active Comparator
Arm Description
Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle
Arm Title
Group Nonechogenic
Arm Type
Placebo Comparator
Arm Description
Non echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle
Intervention Type
Device
Intervention Name(s)
Echogenic needle - Pajunk sonoplex echogenic needle
Intervention Description
Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
Intervention Type
Device
Intervention Name(s)
Non Echogenic needle - Stimuplex Braun Nonechogenic needle
Intervention Description
Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
Primary Outcome Measure Information:
Title
Needle tip and shaft visibility
Description
Percentage Needle Tip & shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time*100
Time Frame
Duration of Block procedure
Secondary Outcome Measure Information:
Title
Duration of block procedure
Time Frame
5- 15 minutes. Start of skin puncture till the final needle removal
Title
Time to onset of sensory blockade
Time Frame
0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test.
Title
Time to onset of motor blockade
Time Frame
0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.
Title
Duration of sensory blockade
Time Frame
0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.
Title
Duration of motor blockade
Time Frame
0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.
Title
Block success rate of echogenic and Nonechogenic group.
Time Frame
Duration of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-60 years, both male and female scheduled for upper extremity surgery
Exclusion Criteria:
Clinically significant coagulopathy
Local anesthetic allergy
Preexisting motor or sensory deficit in the operative limb
Uncontrolled hypertension and unstable Ischemic Heart disease
Body mass index > 35
Patients who needs general anaesthesia for surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinoth kumar, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21425515
Citation
Hebard S, Hocking G. Echogenic technology can improve needle visibility during ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):185-9. doi: 10.1097/aap.0b013e31820d4349.
Results Reference
background
PubMed Identifier
23869186
Citation
Duger C, Isbir AC, Kaygusuz K, Ozdemir Kol I, Gursoy S, Ozturk H, Mimaroglu C. The importance of needle echogenity in ultrasound guided axillary brachial plexus block: a randomized controlled clinical study. Int J Med Sci. 2013 Jul 4;10(9):1108-12. doi: 10.7150/ijms.6598. Print 2013.
Results Reference
background
Learn more about this trial
Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block
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